# K261345: Pediatric Nailing Platform  Femur

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Sep 24, 2026 after 154 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K960642 (1996). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250623: Pediatric Nailing Platform  Tibia Pediatric Nailing Platform  Femur, OrthoPediatrics Corp. (2025) Summary page 5.
- K220679: Pediatric Nailing Platform  Femur, OrthoPediatrics Corp. (2022) Summary page 5.
- K172583: OrthoPediatrics PediNail Intramedullary Platform, Orthopediatrics, Inc. (2018) Summary page 5.
- K233696: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes (2024) Summary page 5.
- K201346: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm, Synthes (USA) Products, LLC (2020) Summary page 5.

## Indications for use
The Pediatric Nailing Platform | Femur is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity; simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. Additional indications of the Pediatric Nailing Platform | Femur Antegrade nails include subtrochanteric fractures and ipsilateral neck/shaft fractures. The Pediatric Nailing Platform | Femur is for single use only.

Source page: https://510kreport.com/device/K261345
Methodology: https://510kreport.com/methodology